Welded back brace

ABSTRACT

A welded orthopedic back brace is disclosed. In an embodiment, at least one belt member is coupled to a spinal support element. The materials of the belt member are thermally fused to form a unitary segment. In another embodiment, an anterior portion of a posterior pad of the spinal support element includes thermally fused materials to provide a user with an added degree of comfort.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of, and claims priority to, U.S.Non-Provisional patent application Ser. No. 15/616,860, filed Jun. 7,2017, entitled “WELDED BACK BRACE,” now pending, which is incorporatedherein by reference in its entirety.

BACKGROUND Field

The present disclosure relate generally to anatomical supports, and moreparticularly, to a compact orthopedic back brace having materials weldedusing thermal fusion.

Background

A number of orthopedic back braces are commercially available forindividuals suffering from various categories of back pain. Such backbraces are configured to serve a number of purposes depending on theapplication to the individual. Generally, orthopedic back braces canassist in providing proper alignment of the spine. Incorrect spinalalignment can cause chronic pain, weakness and other progressiveconditions. Orthopedic back braces typically include a posterior spinalelement for placement against a user's back, and a belt assembly havingone or more belt straps for securing the posterior spinal element to theuser's back. The belt assembly may assist in enabling the posteriorspinal element to press against the relevant area of the user's spine tothereby straighten the spine and relieve discomfort.

Conventional back braces have deficiencies. For example, many or mostsuch orthopedic back braces typically have elements that are sewntogether or otherwise held together using stitches or similar means.Such elements include, among others, the belt straps, which often haveseveral layers that are stitched together at one or more borders inorder to provide a specific amount of rigidity and elasticity to enablethe belt to perform its functions properly. The spinal element typicallyalso involves a collection of materials stitched or sewn together.

Because of the stitching, the internal layers of the belt (or spinalelement) typically are independent of, and can often move relative to,one another. As a result, the separating belt elements can make the beltassembly more voluminous than necessary and undesirable for a wearer.For example, the independently acting layers of the belt member canspread in some areas and bunch up in other areas due to shear forces.The result is a generally unwieldy and bulky fit. Moreover, because eachsuch layer can effective act independently as described above, thedesired properties of the belt (e.g., rigidity, stiffness, elasticity)for achieving a given orthopedic or medical objective often cannot bewell controlled.

Another problem with such conventional back braces is that the physicalproperties and characteristics of the belt typically lack spatialcontinuity. That is, because layers of different materials often simplyoverlap without otherwise being connected except at predefined seams,the properties of the materials (such as the rigidity, flexibility,etc.) can change rapidly at seam borders. More specifically, in areas onthe belt adjacent sewn borders, such belts typically have abruptdiscontinuities in its various properties because different materials(or identical materials with different thicknesses) are directly sewntogether at the predefined borders. Thus, the belt may provide a regionof one or more generally elastic materials that are connected, at a sewnborder, to a rigid, inelastic material. The user can usually feel theseabrupt discontinuities and the attendant discomfort that can result,particularly when the belt is worn for a long time.

Other conventional solutions for the belt assembly have includedcombining a plurality of layers using lamination or an adhesive, such asspray glue. However, such lamination techniques typically involve only apartial application of adhesive over some predefined patterned area ofspots or other shapes on selected portions of the belt layers, with theremaining areas of the belt layers not bonded with adjacent layers andtherefore free to move relative to these adjacent layers. As a result,the layers remain substantially independent and subject to manipulationby shear forces. Further, the physical properties of the laminated beltcannot be modified over different areas of the belt. Additionally,because the layers are not integrated together and are free to move,they add unnecessary volume and bulk to the belt assembly. Glued beltassemblies are also typically not water resistant due to the partialwater solubility of the adhesive. Thus such belt assemblies often alsoemploy stitching techniques to attempt maintain their integrity uponfailure of the lamination. The added stitching requirement makes theassembly process time-consuming and may result in one or more of thefurther disadvantages described above.

These and other shortcomings are addressed in the present disclosure.

SUMMARY

In an aspect of the disclosure, an orthopedic back brace includes aspinal support element and at least one belt member coupled to thespinal support element for securing the spinal support element to auser, wherein the at least one belt member comprises a plurality ofmaterials thermally fused together to form a unitary segment.

In another aspect of the disclosure, an orthopedic back brace includes aspinal support element including an anterior portion of a posterior padconfigured for placement against a spinal area of a user, and at leastone belt member, coupled to the spinal support element, for extendingaround a user's torso to assist in securing the spinal support elementin place, wherein the at least one belt member comprises a plurality ofthermally fused materials configured to form a unitary segment.

In another aspect of the disclosure, an orthopedic back brace includes aspinal support element, and two belt members coupled to the spinalsupport element and configured to secure the spinal support element ontoa user, wherein at least portions of the two belt members includematerials thermally fused together to integrate the materials into asingle segment.

In another aspect of the disclosure, an orthopedic back brace includes aspinal support element comprising an anterior portion of a posterior padconfigured for placement against a spinal area of a user, and at leastone belt member coupled to the spinal support element and configured tosecure the spinal support element onto a user, wherein the anteriorportion comprises a plurality of materials thermally fused together toform a unitary segment.

In another aspect of the disclosure, the orthopedic back brace asdescribed above includes a posterior portion of the posterior pad,wherein the posterior portion includes at least two materials thermallyfused together.

It is understood that other aspects will become readily apparent tothose skilled in the art from the following detailed description,wherein it is shown and described only exemplary configurations of aflexible support by way of illustration. As will be realized, thepresent disclosure includes other and different aspects of a flexiblesupport and its several details are capable of modification in variousother respects, all without departing from the spirit and scope of thepresent disclosure. Accordingly, the drawings and the detaileddescription are to be regarded as illustrative in nature and not asrestrictive.

BRIEF DESCRIPTION OF THE DRAWINGS

Various aspects of the present invention are illustrated by way ofexample, and not by way of limitation, in the accompanying drawings,wherein:

FIG. 1 is a front posterior view illustrating an example of anorthopedic back brace according to the present disclosure.

FIG. 2 is a front anterior view illustrating an example of an orthopedicback brace of the present disclosure.

FIG. 3 shows a front posterior view of the orthopedic back brace of FIG.1 with the posterior cover, posterior frame and posterior cover materialremoved.

FIG. 4 shows a close-up front view of the pulley system.

FIG. 5 shows an anterior view of the orthopedic back brace with theposterior pad removed.

FIG. 6 shows a perspective posterior view of the orthopedic back braceaccording to the present disclosure.

FIG. 7 shows a perspective staggered view of exemplary elements of aspinal support element and their relative order and orientations.

FIG. 8 shows an anterior view of the posterior pad of spinal supportelement of the orthopedic back brace of the present disclosure.

FIG. 9A shows a posterior perspective view of the orthopedic back bracehaving a belt member with an arrow indicating that the belt member is tobe engaged with a D-ring.

FIG. 9B shows a posterior perspective view of the same orthopedic backbrace as FIG. 9A in an alternate orientation.

FIG. 9C shows an anterior perspective view of the same orthopedic backbrace as FIG. 9A-B in another alternate orientation.

FIG. 10 shows a posterior perspective view of the back brace in theprocess of being threaded through the D-ring and being affixed via ahook and loop connection to an anterior portion of the belt.

FIG. 11 shows a posterior perspective view of a foam pad used in thespinal support element in some embodiments.

FIG. 12 shows a posterior front view of the posterior frame having astructure configured to minimize patient discomfort in accordance withan aspect of the disclosure.

FIG. 13 shows an anterior perspective view of the posterior frame havingthe structure configured to minimize patient discomfort.

FIG. 14A discloses a front posterior view of the belt member of theorthopedic back brace.

FIG. 14B discloses a front anterior view of the belt member of theorthopedic back brace

FIG. 15 shows a staggered perspective view of a belt member having itscomponents disassembled into their constituent parts.

FIG. 16A is a front posterior view of a belt member.

FIG. 16B shows a cross-sectional view of the belt member of FIG. 16Aalong plane A-A.

FIG. 16C shows a cross-sectional view of the belt member of FIG. 16Aalong plane B-B.

FIG. 16D shows a perspective view of the belt member of FIG. 16A.

FIG. 17A shows an inverted side view of the belt member of FIG. 16A.

FIG. 17B shows a side view of the belt member of FIG. 16A.

FIG. 18A shows a vertical side view of the belt end segment of the beltmember of FIG.

16A.

FIG. 18B shows a vertical side view of the belt member of FIG. 16A asviewed from a proximal end section of the belt to the distal belt ansegment.

FIG. 19A shows a perspective view of a belt assembly disposed betweentwo tooling molds for use in thermally fusing the belt assembly.

FIG. 19B shows an inverted perspective view of the belt assembly andtooling molds of FIG. 19A

DETAILED DESCRIPTION

Various aspects of an orthopedic back brace will now be presented.However, as those skilled in the art will readily appreciate, theseaspects may be extended to other anatomical supports without departingfrom the spirit and scope of the present disclosure. The detaileddescription set forth below in connection with the appended drawings isintended to provide a description of various exemplary embodiments oftechniques for an orthopedic back brace and is not intended to representthe only embodiments in which the invention may be practiced. The term“exemplary” used throughout this disclosure means “serving as anexample, instance, or illustration,” and should not necessarily beconstrued as preferred or advantageous over other embodiments presentedin this disclosure. The detailed description includes specific detailsfor the purpose of providing a thorough and complete disclosure thatfully conveys the scope of the invention to those skilled in the art.However, the invention may be practiced without these specific details.In some instances, well-known structures and components may be shown inblock diagram form, or omitted entirely, in order to avoid obscuring thevarious concepts presented throughout this disclosure. The variousaspects of the present disclosure illustrated in the drawings may not bedrawn to scale. Rather, the dimensions of the various features may beexpanded or reduced for clarity. In addition, some of the drawings maybe simplified for clarity. Thus, the drawings may not depict all of thecomponents of a given apparatus or method.

In accordance with various aspects of the present disclosure, a weldedorthopedic back brace is provided. In one aspect, the back braceincludes one or more belt members having materials thermally fusedtogether to integrate the materials to form the one or more beltmembers. The use of thermal fusion to create the belt members providesfor a number of advantages over conventional techniques. As an example,the welded nature of the belt members integrates the belt materialstogether in a manner such that the corresponding belt member form asingle, unitary segment. This is in contrast to conventional techniques,most of which use sewing or stitching of a number of essentiallyindependent layers to form the belt members.

In these conventional techniques, as discussed briefly above, often twoor more materials are placed on or adjacent each other and are sewnlongitudinally along the belt borders or in other locations on the beltmember. As a result of this configuration, conventional belt memberstend to cause a user unnecessary discomfort, particularly when worn forlong periods of time. This is in part because the materials are onlyattached together at specific stitching points and as such, thematerials tend to separate in areas away from those specific stitchingpoints. To this end, the various materials of the belt tend to actindividually and/or independently of each other, as described above.That is, when the back brace is donned by a user and the belt is fitsnugly around the user's waist, the materials often bunch up inundesirable areas and otherwise move in unpredictable ways.

Among other problems, these phenomena generally cause discomfort to theuser by adding various pressure points where the material is thickest orin areas where the material has congregated when the belt is worn. Thediscomfort can be exacerbated in belts that are stitched at or nearsensitive parts of a user's anatomy. For example, the stitched bordersmay in some cases exert substantially more pressure on a user's waistthan in areas where less or no stitching is present. In apparentrecognition of these deficiencies, practitioners have made variousefforts to address them by adding additional layers or thickness to thebelt in an effort to reduce discomfort.

However, the addition of extra layers as an attempted solution tends toultimately make the stitched belt members unnecessarily voluminous. Eachlayer of material that constitutes a portion of the belt member isgenerally an individual piece of material and as such, contributes tothe overall volume of the belt. The volume of the belt is somethingwhich can exacerbate problems with users who are self-conscious aboutwearing such devices in public. In many cases, the volume of theseconventional belts is so large that it is not practicable for a user towear attire over the belt. Rather, the belt must be worn externally,which can contribute to the negative perceptions sometimes associated byusers with such orthopedic devices.

Still other conventional solutions involve the use of a laminate oradhesive such as spray glue over partial regions of the belt layerswhich, as described above, tends to add unnecessary cumulative volume tothe belt and renders it difficult if not impossible to control criticalproperties of the belt across specific areas. Further, as indicatedabove, laminated belt assemblies include substantially independent beltlayers that remain subject to shear forces and glue failures. Theseconventional solutions also tend to produce abrupt discontinuities inareas where the layers change (e.g., where a layer is removed orthinned), more often than not resulting in noticeable user discomfort.

In addition, the belt members serve very important functions in theoverall device—for example, to enable a secure but comfortable fit ofthe posterior in order to straighten the spinal column. To accomplishthis function, the materials selected for use in the belt members andtheir characteristics (thickness, elasticity, solidity, rigidity,firmness, volume, etc.) generally must be carefully selected in order toachieve a specific set of results for the belt, depending on the user orthe application. For example, the belt members generally need to usematerials that include properties like elasticity, rigidity, stiffness,etc., in order to both be efficacious and to provide comfort to theuser. In conventional back braces, this process is often accomplished byselecting materials having entirely different properties and bystitching the disparate materials together. As a result, there oftenexists a significant gradient in areas of the belt member where thematerials, and hence the belt properties, change, which in turn is aneffect felt by the user. For instance, many conventional back bracesstitch an elastic material to a rigid material. The sharp difference inelasticity on one portion of the belt (and consequently on one portionof the user's body) and rigidity on another immediately adjacent portionof the belt can be fairly conspicuously felt by a user, and is an addeddiscomfort. Yet another problem with this approach is that, more oftenthan not, it is difficult to obtain a predictable set of combinedproperties across specific regions of the belt materials that wouldrender the belt assembly an optimal solution for a specific orthopedicapplication.

In contrast to these techniques, with respect to certain embodiments tobe discussed below, at least a portion of the belt materials are weldedtogether. That is, rather than exclusively using stitching or anothermethod, at least a portion of the belt materials are thermally fused toessentially form a single, unitary segment. Because the belt materialsare thermally fused instead of sewn, the belt members have a naturallylow profile with a compact volume that tends to be much smaller thanexisting solutions. As described below with reference to FIG. 15,thermal fusion produces an overall compression of the constituentmaterials. Further, using the thermal fusion process as describedherein, it is generally easier for a developer to accurately design andachieve predictable and continuous properties over specific areas orregions of the belt. This is in part due to the fact that the beltbehaves as a unitary segment rather than as a collection of individualmaterials with substantially different properties and different degreesof directional freedom. As described in greater detail below, weldingthe materials causes the materials to become permanently affixedtogether across all welded regions, in contrast to the conventionalapproaches that rely purely on stitching or lamination.

Additionally, the back brace according to the present disclosure tendsto avoid sharp gradients in property transitions of materials. Thisbenefit is due to the ability of thermal welding to integrate the fusedmaterials together. For example, when a segment of a generally rigidmaterial is thermally fused with a segment of generally elasticmaterial, the area corresponding to the thermal fusion typically hasproperties that include the properties of both of the fusedmaterials—namely, some amount of elasticity and some amount of rigidity.This gradual transition of material properties, rather than sharpgradients produced by conventional means, generally results in a muchmore comfortable user experience. This, combined with more compact andlower profile belt members, results in a back brace that is far morelikely to be worn by a user as recommended by a medical professional.

FIG. 1 is a front posterior view illustrating an example of anorthopedic back brace 100 according to the present disclosure. FIG. 1,more specifically, shows an outer view of the back brace 100, i.e., awayfrom a user's waist. The back brace 100 in this embodiment shows beltmembers 102 and 104 respectively coupled to a spinal support element 114via D-rings 126 a and 126 b. Although for purposes of this embodimenttwo belt members are utilized, a single belt maybe be equally suitable.Further, while the D-rings coupling the belt members are discussed ingreater detail below, it should be understood that the belt members maygenerally be coupled to the spinal support element 114 in any suitableway. In some embodiments in which a single belt member is utilized, thebelt member may be movably or non-movably coupled to the spinal supportelement 114 via a slit or other connection mechanism.

Spinal support element 114 generally includes a posterior cover 117,posterior cover window 122 and posterior cover material 120. In oneexemplary embodiment, the outer part of posterior cover 117 is composedof thermoplastic polyurethane (TPU) and the posterior cover material 120is a mesh material. In another exemplary embodiment, the cover material120 is substantially transparent and has breathable properties forenabling airflow into spinal support element 114. Each of belt members102 and 104 include respective belt end segments 106 and 108. In oneembodiment, belt end segments 106 and 108 are composed of unbroken loopmaterial (UBL). In another embodiment, only belt end segment 106 iscomposed of UBL and is used to engage with an opposing segment on ananterior side of the belt, as shown with reference to FIG. 2. In otherembodiments, belt end segments 106 and 108 are composed of anothersuitable material. In still other embodiments, belt end segments 106 and108 may have different shapes, or simply end on one or both sides in arectangular shape corresponding to the remainder of the belt shape ofthe belt members 102 and 104. Belt end segments 106 and 108 constitutesquares, rectangles, ellipses, or any other shape.

Belt members 102 and 104 also include an exterior layer 119 a on oneside (belt member 102), and 119 b on the other side (belt member 104).In an exemplary embodiment, exterior layers 119 a-b are composed of TPU.Further, in this embodiment, exterior layers 119 a-b include a series ofangled oblong capsule-like shapes that run longitudinally along beltmembers 102 and 104. It should be noted that different structurescomposed of the same material may have different thicknesses and otherproperties and may be composed of other or different elements orcombinations thereof.

Belt member 102 further includes winged members 116 a on belt member 102and 116 b on belt member 104. In an exemplary embodiment, winged members116 a-b are also composed of UBL. Belt members 102 and 104 may alsoinclude regions 110 and 112 of material that extend longitudinallythereacross. In an exemplary embodiment, regions 110 and 112 arecomposed of UBL. In this embodiment, UBL is provided to enable hookmaterial disposed on pull rings 122 a and 122 b to attach to regions 110and 112, respectively, so that they can be secured and easily located asnecessary by a user. However, in other embodiments regions 110 and 112may be composed of hook material or another suitable material. It willbe appreciated that these details of the belt members 110 and 112 arefor purposes of illustration and that many different types, shapes andconfigurations of materials may be contemplated.

Affixed to belt members 102 and 104 can further be seen pull rings 122 aand 122 b. The pull rings are used to provide tension to a pulleyassembly (obscured from view) via pulley ropes 124 a and 124 b. In otherembodiments, only a single pull ring may be more suitable. As describedfurther below, the pull rings 122 a-b enable a user to makemicro-adjustments to the fit of the back brace.

FIG. 2 is a front anterior view illustrating an example of theorthopedic back brace shown in FIG. 1. FIG. 2 includes an anterior viewof spinal support element 114. In this embodiment, spinal supportelement 114 includes a posterior pad 202 configured to comfortably restflush against a designated spinal region of a user. Thus, from thefigure, an anterior portion 214 of the posterior pad 202 is visible.While the embodiment shown in FIG. 2 includes a spinal support element114 having a posterior pad 202 as one component of the spinal supportelement 114, it will be appreciated that spinal support element 114 neednot be so limited and may be configured in a number of ways depending onthe user's needs.

Posterior pad 202 further includes pad spacer section 204 and pad meshelement 207. In one exemplary embodiment, pad spacer section 204constitutes a single pad of 3-D spacer mesh material overlaid by the padmesh element 207. While any number of materials can be suitably used,3-D spacer mesh material is known for its comfort, cushioning, strength,breathability design efficiency, and versatility. Posterior pad 202 isfurther composed of mesh section 207. In an exemplary embodiment, meshmaterial is used in section 207 to ensure comfort and breathability.These considerations are especially significant given that in thisembodiment, section 207 may rest substantially flush against the spinalarea of a user. The user, in turn, may be experiencing pain, or may haverecently had spinal surgery in this region. The use of mesh in section207, and 3-D spacer in section 204, assists in providing more comfort tothe user than existing solutions. In other embodiments, the entireanterior portion 214 of posterior pad 202 may be made of a singlematerial, such as mesh. In one aspect of the disclosure, the meshsection 207 and the respective pad spacer elements 204 may be coupledtogether at segments 216 via a thermal fusion process as describedfurther below with reference to FIG. 8.

Referring still to FIG. 2, the anterior portion of belt members 102, 104are shown and include belt end segments 206 and 208, which correspondrespectively to belt end segments 106 and 108 of FIG. 1. In oneembodiment, the material of the anterior portion 221 of belt members 104and 102 and belt end segments 206 and 208 may be composed of a 3-Dspacer mesh material for providing a user with comfort, durability andcushioning. Additionally, associated with belt end segment 208 is aconnection portion 210. In one embodiment, connection portion 210 onbelt member 104 may be composed of hook material. Connection portion 210thereby enables the user to securely affix the belt around the user'swaist or torso by securely engaging the hook material of the connectionportion 210 with the UBL material on the opposing belt member 102 otherside of the belt, i.e., in sections 106 and 110 (see FIG. 1). It isnoted again that while specific configurations of hook and UBL materialare recited, these details are presented for purposes for illustrationand are not intended to limit the scope of the invention. In otherembodiments, for example, another equally suitable connection means maybe employed in lieu of hook and loop material.

Each of belt members 102 and 104 in FIG. 2 further include wingedmembers 220 a on belt member 102 and 220 b on belt member 104. In anembodiment, the winged members 220 a-b are composed of UBL.

FIG. 3 shows a front posterior view of the orthopedic back brace of FIG.1 with the posterior cover 117, posterior cover window 122 and posteriorcover material 120 removed. As is more readily apparent from this view,belt members 102 and 104 are coupled to spinal support element 114 via apulley system 302 and D-rings 126 a and 126 b. More specifically, inthis exemplary embodiment, belt member 102 is threaded through D-ring126 a and is coupled to an anterior side of the belt member 102 via ahook and loop connection. Thus, for example, an anterior side of thebelt member 102 may contain areas of hook material closer to the inneranterior edge (not shown) of belt member 102 that mate with the UBLmaterial on winged members 220 a (see FIG. 2). Similarly, in thisembodiment, belt member 104 is threaded through D-ring 126 b and iscoupled to an anterior side of the belt member 104 via a hook and loopconnection. For example, an anterior side of the belt member 104 mayalso contain areas of hook material closer to the inner anterior edge ofbelt member 104 that mate with the UBL material on winged members 220 b.These embodiments are described further with respect to FIGS. 9A-C,below.

Thus, more simply, belt members 102 and 104 in this embodiment aresecurably coupled to spinal support element 114 via their fold-over hookand loop connection on the anterior side of the belt members 102 and104. It will be appreciated that other embodiments may be equallysuitable for coupling the belt members to the spinal support element.For example, the belt members 102 and 104 may in alternative embodimentsbe permanently affixed to spinal support element 114, via D-rings 126 aand 126 b or otherwise. In other embodiments, the belt members 102 and104 may be threaded through D-rings 126 a-b such that the belt mates viaa hook and loop connection on the posterior side rather than theanterior side, as shown. Numerous other arrangements may be equallysuitable depending on the application and objectives.

FIG. 3 further shows that D-rings 126 a-b are coupled to spinal supportelement 114 via a pulley system 302 (FIG. 4). Also shown in FIG. 3 aspart of spinal support element 114 is posterior frame 304. In oneembodiment, posterior frame 304 comprises a plastic pad designed andshaped to fit the contour of the spinal region of a user of a particularsize. Posterior frame 304 may include a specific amount of rigidity soas to adequately influence a position, and/or maintain a properalignment, of the spinal column of a user. Posterior frame 304 includesa plurality of capsule-shaped orifices 306 and 308 disposed across backpad 304 and configured to provide breathability. The use of orifices 306and 308 may also influence the flexibility of posterior frame 304. Ingeneral, posterior frame 304 is composed of a material having athickness and geometrical shape that is suitable for providing therequisite spinal support given the medical or orthopedic application.

In some embodiments, posterior frame 304 may include, or be coupled to,one or more additional pads positioned between posterior frame 304 onone hand, and posterior pad 202 (FIG. 2) on the other hand, for furthersupport and to provide additional levels of cushioning andbreathability. For example, posterior frame 304 may overlay another foamback pad and/or back wing section which is then covered by posterior pad202 (FIG. 2). In one embodiment, to provide a layer of extra comfortwith breathability, a foam pad with orifices (FIG. 11) is insertedbetween the posterior frame 304 and posterior pad 202. The details andconfiguration of the back panels may, in short, vary in accordance withthe embodiment and application.

FIG. 4 shows a close-up front view of the pulley system 302 inaccordance with the present disclosure. In one embodiment, the D-rings126 a and 126 b of pulley system 302 are respectively coupled toposterior frame 304 via any suitable connection means, such as a directplastic connection or a slidable connection using plastic protrusionsslidably engaged with slits in posterior frame 304, etc. As discussedabove, once a user has donned the back brace and engaged the belt memberat the front of the user's body, the user can provide micro-adjustmentsto the fit of the back brace by pulling on pull rings 122 a and 122 b,which in turn provides tension to pulley ropes 124 a and 124 b. Pulleyrope 124 a is threaded through guide 412 and winds around varioussections of pulley posts 404 before termination at the anchor 408.Similarly, pulley rope 124 b is threaded through guide 410 and windsaround various sections of pulley posts 402 before being terminated atanchor 406. Using the pulley system as is conventionally known, thetension on the pulley ropes 124 a-b causes the D-rings to exert lateralforces on spinal support element 114 (or components thereof) such thatthe spinal support element can be more securely tightened across theuser's spinal region. The D-rings 126 a-b may be (slidably coupled) toposterior frame 304 for engaging the back pad 304 in response to tensionfrom pulley ropes 124 a-b, as discussed further below.

In alternative arrangements, a single pulley rope may be used to providethe force to tighten the back brace. In still other configurations, apulley system is not employed, and the belt members are coupled directlyto spinal support element 114 and adjustment is performed by the userproviding tension directly to the belt member(s).

FIG. 5 shows an anterior view of the orthopedic back brace 500 with theposterior pad 202 (FIG. 2) removed. An anterior side of posterior frame304 (FIG. 3) is shown. Posterior frame 304 includes orifices 306 and 308for breathability and for accommodating various design considerations asknown in the art. Posterior frame 304 may be secured to other componentsof spinal support element 114 via attachment openings 310 or othersuitable methods. Horizontally disposed orifices 312 are, in anembodiment, used to enable a connection to D-rings 126 a-b (FIG. 4).More specifically, the underside of D-rings 126 a-b (relative to aviewer of the posterior side of the back brace (FIG. 1)) may includeplastic extrusions that protrude through orifices 312 and are secured onthe opposite side of the orifices by flaps or other elements. Thisconfiguration enables D-rings 126 a-b to be slidably coupled toposterior frame 304 and to engage and tighten the posterior frame 304when tension on the pulley strings 124 a-b is provided. Orifices 312, insome embodiments, may provide further positive design characteristics,may be used with connectors, and/or may beneficially affect thebendability of the spinal support element 114. As indicated above, inother embodiments spinal support element 114 may include additionallayers or components made of plastic, foam or other material disposedbetween posterior frame 304 and posterior pad 202. For example, a 3-Dspacer mesh wing pad and/or another foam pad (FIG. 11) may be used toadd additional breathable comfort to accommodate various designconsiderations.

FIG. 6 shows a perspective posterior view of the orthopedic back brace600 according to the present disclosure. Portions of back brace 600 havebeen disassembled for clarity. Belt members 102 and 104 are coupledrespectively to spinal support element 114 via D-rings 126 a-b andpulley system 302 (FIG. 3). Also shown is exterior layer 119 a-bdisposed longitudinally across the respective belt members 102 and 104.Further shown is posterior cover 117, posterior cover window 122, andposterior cover material 120. In an embodiment, posterior cover 117,posterior frame and posterior cover material 120 are welded together viaa thermal fusion process as described herein.

FIG. 7 shows a perspective staggered view of exemplary elements of aspinal support element 114 and their relative order and orientationsaccording to an exemplary embodiment. Thus, FIG. 7 illustrates how thevarious components may be stacked together to form spinal supportelement 114. These details are illustrative in nature and a large numberof different embodiments using more or substantially less layers ofelements or materials may be equally suitable in other embodiments.

Towards the left side of FIG. 7, the components comprising the posteriorportion of spinal support element 114 are shown (i.e., that portionopposite the user's back). Similarly, towards the right side of FIG. 7,the components comprising the anterior portion of spinal support element114 are shown. That is to say, certain components are configured to beflush against a user's back as set forth in greater detail below.

Starting from the left, posterior cover window 122 may be affixed toposterior cover 117. In turn, posterior cover 117 may be affixed toposterior cover material 120. In various embodiments, two or more ofposterior cover window 122, posterior cover 117 and posterior covermaterial 120 are thermally fused together to form a more compact andintegrated posterior cover of spinal support element 114, whicheliminates the need for stitching. In other embodiments, stitching oradhesives may be use to combine these materials. In still otherembodiments, the entire network of materials or some portion thereof maybe welded together to form a unitary sleeve or cover.

Posterior cover material 120 is thereupon shown adjacent posterior frame304 (FIG. 3). It should be noted that the pulley assembly 302 andassociated D-rings 126 a-b are not shown here for ease of clarity.However, as discussed above, D-rings are generally coupled to a surfaceof posterior frame 304. Referring still to FIG. 7, posterior frame 304is affixed flush against foam pad 702. In an embodiment, foam pad 702 isan open cell foam or styrene foam material used to provide cushioningand breathability for the user. Foam pad 702, in turn, is secured to padspacer section 204, which is affixed to pad mesh element 207. Pad spacersection 204 and pad mesh element 207 form an anterior portion ofposterior pad 202 of spinal support element 114, which anterior portionrests flush against a user's back.

Generally, one or more of the structures of FIG. 7 may be included inthe spinal support element 114. The elements may be affixed or attachedto one another in a variety of ways. In some exemplary embodiments, oneor more of the elements of FIG. 7 are placed flush against each otherwith no direct connection. In other embodiments, one or more of theelements of FIG. 7 are affixed together at or near respective borderareas of the elements, or other areas. The manner of connection may varywidely and may involve one more of adhesives, thermal fusion as hereindescribed, clamping mechanisms, or other hardware elements used forconnection means.

In an exemplary embodiment, posterior cover window 122 is composed ofsubstantially transparent breathable mesh material that enables a viewerto observe the interior of the spinal support element 114. Posteriorcover material 120 may also be substantially transparent such that aviewer can observe portions of the pulley system 302 and the posteriorframe 304 via posterior cover window 122, as is most evident withreference to FIG. 1. This window and the transparent mesh materialprovides additional relief to the user because each layer of thestructure of FIG. 7 provides breathability. The resulting spinal supportelement 114 consequently enables air to flow from an area external toposterior cover window 122 via the various structures to the user'saffected area, which may reduce itching and irritation and risk of skininfection, and which may promote healing. This is in contrast toconventional back braces in which the affected area may be substantiallylimited or altogether obscured from external exposure of air.

FIG. 8 shows an anterior view of the posterior pad 202 of spinal supportelement 114 of the orthopedic back brace. In this embodiment, spinalsupport element 114 includes a posterior pad 202 composed of pad spacersection 204 and pad mesh element 207. In one configuration, thematerials are welded together using thermal fusion. For example, padmesh element 207 is thermally fused along regions 802 a and 802 b to padspacer section 204. Pad spacer section 204 may, in turn, be welded toother materials included in spinal support element 114 to create a thin,low profile support. For example, pad spacer section 204 may bethermally fused to foam pad 702 (FIGS. 7 and 11) and/or to posteriorcover 117 on the other side of the spinal support element 114. In thislatter embodiment, pad spacer section 204 may constitute a sleeve thatis thermally welded at the borders of the spinal support element 114 tothe posterior cover 117 on the posterior side of the spinal supportelement 114. Thus, in this embodiment, the materials on the anterior andposterior sides of spinal support element 114 may be at least partiallywelded together such that spinal support element 114 is a substantiallyintegrated and unitary component.

Referring back to FIG. 8, two strips of material 802 a and 802 b areused both to define the borders between pad spacer section 204 and padmesh element 207 and to facilitate the thermal fusion process by actingas an intermediate or filler material, as discussed further below. In anexemplary embodiment, the strips of material 802 a-b are composed ofUBL, although various other materials may be equally suitable.

The use of welded materials on the anterior portion of posterior pad 202of spinal support element 114 provides numerous advantages. For example,pad spacer section 204 may be welded to the pad mesh element 207 usinganother material, such as a thin strip of UBL tape disposed alongsegments 802 a-b, to facilitate a weld having a smooth and comfortabletransition. This feature is in contrast to conventional techniques whichuse stitching on the posterior pad. The use of stitching causes smallbut noticeable “bumps” or rigid protrusions in the material along theborders of the stitched materials. Since the anterior portion of theposterior pad 202 is flush against a user's spine, the rigid protrusionsresulting from stitching are usually noticeable and potentiallyuncomfortable for a user, especially after long periods of use. Thewelding, as discussed above, enables a smooth transition between padmesh element 207 on one hand, and 3-D spacer elements 204 on the otherhand, such that any rigid protrusion otherwise formed through astitching process is eliminated.

More fundamentally, the welded nature of the materials helps provides alow profile, lightweight spinal support element. Welding the materialsprovides a manufacturer with the ability to use different materialstogether even if the materials have otherwise disparate properties. Thisis in contrast to conventional back braces, which typically are morelimited in their use of materials. Manufacturers of these conventionalbraces generally must use thicker materials to avoid stretchingproblems, which only increases the bulk of the back brace. In the backbraced described herein, by contrast, comfortable segments of varioustypes of materials such as different mesh materials may be seamlesslybound together. The use of such porous materials provides furtherbreathability and comfort to the user.

Still referring to FIG. 8, the welding of pad mesh element to 207 andpad spacer section 204 is such that foam pad 702 is partially visiblevia the window composed of pad mesh element 207 and pad spacer section204. The capsule shaped orifices contained in the foam pad 702 may bevisible, or partially visible, through the pad spacer section 204 andpad mesh element 207. Generally, the configuration of spinal supportelement 114 and its constituent components may vary in a number of waysdepending on the application and objectives for the back brace andremain within the spirit and scope of the present disclosure.

Referring to FIG. 9A, an exemplary embodiment is shown for macro-fittingthe belt around the waist of the user by using the end sections 902 and904 of the belt members 102 and 104 proximate to the spinal supportelement 114. FIG. 9A shows a posterior perspective view of theorthopedic back brace having belt member 104 with an arrow indicatingthat belt member 104 is to be engaged with D-ring 126 b. Thus, as partof a first step if the belt is not already assembled, a user or otherprofessional can engage the belt members 102 and 104 with respectiveD-rings 126 a-b.

FIG. 9B shows a posterior perspective view of the same orthopedic backbrace as FIG. 9A in an alternate orientation.

FIG. 9C shows an anterior perspective view of the same orthopedic backbrace as FIG. 9A-B. The anterior portion of belt member 104 includeswinged members 220 b, which may be composed of a hook and loop materialsuch as UBL. Further shown on belt member 104 are square-shaped regions906 a and 906 b positioned near the end 904 of the belt member 104. Inan embodiment, in a case where the winged members constitute UBLmaterial, the corresponding squared sections 906 a-b are composed ofhook material and are ultimately used to engage with the winged members220 b to secure the belt at the correct macro-fit. FIG. 9C further showsbelt member 102 already threaded through D-ring 126 b and securablyfastened via a hook and loop connection using similar hook squares onbelt 102 to engage with the UBL winged members 220 a.

FIG. 10 shows a posterior perspective view of the back brace in theprocess of being threaded through the D-ring 126 b and being affixed viaa hook and loop connection to an anterior portion of the belt (at wingedmembers 220 b (FIG. 9C)). It can be seen more clearly in FIG. 10 that inthe embodiments of FIGS. 9A-C and 10, the belt end is threaded throughD-ring 126 b such that belt end 904 will be affixed to an anterior orinner portion of belt member 104. However, in alternate configurations,the belt members may fold through the D-rings 126 a-b or other slitcomponents in the opposite direction such that belt ends 902 and 904 andtheir respective hook sections 906 a-b engage a posterior or outer sideof the belt (such as engaging with UBL on winged members 116 b in FIG.1), instead of the belt members 102 and 104 being folded inward as inthe embodiment shown. In alternative embodiments, the location and shapeof the various hook and loop elements may vary. In still otherembodiments, the one or more belt members may be permanently affixed tothe spinal support element 114, via other components or directly.

FIG. 11 shows a posterior perspective view of foam pad 702 used in thespinal support element 114 in some embodiments. As described above, foampad 702 may be made of a suitable material such as open cell foam orstyrene foam for providing cushioning support to a user. Foam padfurther provides breathable orifices 805 to further facilitate the flowof air in and out of the spinal support element structure 114 forpatient comfort. In an embodiment, the orifices are die cut.

FIG. 12 shows a posterior front view of posterior frame 304 having astructure configured to minimize patient discomfort in accordance withan aspect of the disclosure. As discussed in connection with previousembodiments, posterior frame 304 may be a generally semi-rigid structureused to provide the necessary support to the spinal column when the backbrace is worn by a user. As noted previously, posterior frame 304includes various capsule shaped orifices 306 for breathability and insome embodiments, for effecting the bendability or other designconsiderations relevant to the posterior frame 304 for maximumeffectiveness. Further shown are orifices 312 to enable the posteriorframe 304 to slidably connect to the D-rings 126 a-b in accordance withan exemplary embodiment.

Oftentimes, the user of the back brace has just gone through surgery orotherwise has bruising, pain or other trauma to the affected area of thespine over which the orthopedic back brace is configured to operate. Inconventional back braces, the rigid or semi-rigid portion of a spinalpad can serve to significantly exacerbate the pain of the user. This isparticularly true where the user has surgical wounds or other trauma inthe affected area. In these cases, conventional back braces, due to therigidity in the area of the plastic spinal pad, tends to provide asignificant amount of force and pressure to the affected area, tendingto cause a user afflicted with such trauma considerable pain. As aresult, the user is less motivated to wear the back brace.

Accordingly, in one aspect of the disclosure, a set ofstrategically-positioned perforations in posterior frame 304 enable abreathable and movable “doorway” to partially open and provide relief tothe user by avoiding excess or undue pressure on the injured area. Asseen in FIG. 12, posterior frame 304 includes a generally central regionpositioned between line segment 1208 which is the area that is typicallydirectly against the injured area. In FIG. 12, perforations 1202 a and1202 b in the plastic material are provided and are connected togetherby another orthogonally-disposed perforation 1204. Additionalperforations 1206 a and 1206 b run transversely through perforation1204, and perforations 1206 c and 1206 d run orthogonally to perforation1202 b, such that a network of perforations is defined. This networkultimately defines a pair of flaps 1220 a and 1220 b. When theorthopedic back brace as described herein is donned by a user, thenetwork of perforations, and particularly perforations 1202 a-b and1204, enables the flaps 1220 a-b to partially open to thereby relievepressure due to spinal processes (e.g., natural spinal movements) on theaffected area of the user's spine. In this way, the orthopedic backbrace of the present disclosure provides the necessary amount ofcompression and adjustment to the spinal region without causing furthertrauma or unnecessary pressure on the affected area of the user.

In the embodiment shown, perforations 1206 a-d have been strategicallyplaced to further allow a user to connect the posterior frame 304 ofspinal support element to a single or double loop on a user's pant toprevent unwanted sliding or movement of the orthopedic back brace whenthe user sits or performs other movements. Additionally, perforations1206 c-d and a portion of perforation 1202 b may produce another flaporthogonal to flaps 1220 a-b, which flap may be used to clip onto anedge of a user's pant in lieu of using a belt loop connection.

In addition, in some embodiments, perforations 1206 a-d, or positionalvariations of such perforations, may be configured to provide additionaldegrees of freedom or orientations such that the flap sections 1220 aand 1220 b (and segments within the flap sections 1220 a and 1220 b) canmove in slightly different orientations to further relieve unduecompression in an injured spinal area while maintaining an effectiveoverall compression to straighten the spine.

In short, flaps 1220 a-b can be made to provide comfort and support andpressure relief in the most delicate area of the user's spine, and thissupport can be provided, in one embodiment, by enabling the network ofperforations to allow the segments and flaps 1220 a-b to partially open.Advantageously, such flaps also provide a mild pressure gradient ratherthan a sharp change in compression as in conventional approaches. Inparticular, conventional attempts to address this problem include theuse of small “windows” or holes in the frame of a back brace. Unlike theflexible flap structure as described in the present disclosure, theseconventional window mechanisms tend to compress against the user's backand cause the user to experience “window edema” in which substantialpain and swelling within the confines of the window area may occur.Also, these conventional windows intrinsically include sharp demarcationlines defined by the window perimeter, which lines can result in abruptand painful pressure differences on the affected area.

The above-described flap solution, by contrast, provides gradientsupport and relief, and substantially eliminates the deficiencies causedby sharp edges per conventional solutions. The gradient support asdescribed above also reduces pressure on the affected areasignificantly, including when the user is sitting, while concurrentlymaintaining the structure of the posterior frame 304.

It will be appreciated that, while a specific network of perforations isdescribed herein to effect the desired objectives, the principles of thepresent invention can be practiced using different configurations, anddifferent networks or types of perforations. That is, the segments 1220a and 1220 b and the associated network of perforations is illustrativein nature, and any number and shape of perforations, flaps, etc., can befurther designed to accommodate the sensitive areas of the patient'sspinal region without departing from the spirit and scope of theteachings herein.

FIG. 13 shows an anterior perspective view of the posterior frame havingthe structure configured to minimize patient discomfort. The anteriorside 1210 of posterior frame 304 is slightly angled outwardly about anaxis defined by line 1208. Thus, when the posterior frame 304 iscompressed against a user's spine as the user dons and properly fits theback brace, the overall structure of posterior frame 304 provides thecompression and spinal support needed for the user while the network ofperforations located in an affected area of the user can extendoutwardly to relieve pain and uncomfortable pressure on the user'sspine, including on a recent surgical scar or an injury.

In another aspect of the disclosure, a compact and low-profileorthopedic back brace is disclosed which uses thermal fusion tointegrate together the materials in the belt member. As noted above,conventional back braces use stitching as a primary means of assemblingthe belt members. As a result, conventional back braces are unduly largeand bulky. As for the stitched belt members of the present art, thevarious layers are bulky and are generally independent of one another.Because they are independent, they tend to separate in some areas andcongregate or “bunch up” in other areas. It is the experience of theinventors that users generally prefer smaller and more compactorthopedic devices, given, among other problems. the potential forparticularly self-conscious people to avoid wearing the devicesaltogether.

In addition to their bulkiness and layer independence of the beltmembers, conventional back braces have other deficiencies. Oftentimes itis desirable to use materials in the belt member(s) having differentproperties or characteristics in order to achieve a particularobjective. Such particular objectives may include, by way of example, aspecific amount of rigidity in various areas of the belt member and aspecific amount of elasticity in other areas of the belt member.Sometimes it is desirable to combine these characteristics and obtainspecific degrees of rigidity, stiffness, elasticity, or specificgradients of such characteristics across the area of the belt members.Conventional back braces endeavor to obtain these objectives bystitching disparate materials together.

For example, such conventional back braces may have belt members withregions in which two versions of a given material—one thick and theother thinner—are stitched together. Additionally, such conventionalback braces may have belt members with different types of materialsstitched together to achieve the aforementioned objectives. Asignificant disadvantage to this process is that where materials havingdifferent characteristics are stitched together at some border regionalong a surface of the belt member, that border region will generally becharacterized by a sharp and abrupt discontinuity in the physicalcharacteristics and properties of the belt member along that borderregion. For example, a conventional back brace may use a belt memberhaving a thick, relatively inelastic material that in turn is sewn to arelatively elastic material. The properties at the stitched regionchange dramatically from inelastic to elastic—a change that may resultin uncomfortable pressure points or other anomalies, and one is moreoften than not noticeable to the user of such conventional back braces.

In contrast to conventional back braces, a more compact andlower-profile orthopedic back brace includes materials welded together,at least in part, by thermal fusion. Generally, welding is a processwhere two or more pieces of materials such as thermoplastics, foam,mesh, etc., are fused together by use of heat, pressure and the passageof time. The process of applying heat softens the material and enablesit to affix or fuse to another material when an adequate amount ofpressure is applied. A filler material may be used in some thermalfusion processes, such as the use of an adhesive to join two materialsthat have properties that are not necessarily amenable to the weldingprocess without the filler material.

Different types of welding are available and any suitable weldingtechnique may be contemplated herein. Additionally, different types ofweldable materials are available, each with different meltingtemperatures or bonding properties. These and other variables dictatevarious factors like whether two different materials can be thermallyfused together directly, or whether an additional filler material isdesirable.

Some examples of welding methods include heat press, RF welding, sonicwelding, and a number of forms of high frequency welding. Depending onmaterials and bonding methods, different bonding and meltingtemperatures of the materials are involved in the typical weldingprocess. In general, the temperature range is 90 C-250 C, but this rangemay not be applicable to all such processes, and some temperatures maybe higher or lower than the aforesaid range. Radio frequency (RF), sonicand most forms of high frequency welding create heat by vibratingmaterials against each other. This phenomenon enables the materials tocreate their own heat energy, which in turn fuses the materials. Othermethods of thermal fusion may include use of a heat press, wherebyapplication of high temperature to the layers thermally fuses them. Inone embodiment, high frequency welding is used to create the orthopedicback brace described in the present disclosure.

In contrast to the conventional back braces described above, the thermalfusion process heats the materials and with added pressure, causes thematerials to fuse as a substantially integrated unit around the fusionareas. Thus, at the region of thermal fusion, the resulting integratedmaterial typically possesses collective characteristics or properties ofeach of the constituent original materials. As a result, at regionswhere the materials are fused together, a gradual gradient or change inmaterial characteristics (e.g., rigidity, elasticity, stiffness, etc.)can be designed and implemented in the belt member. As a result, when auser wears the orthopedic back brace as described wherein, the user ismuch less likely to notice abrupt discontinuities resulting from thesephenomena. This effect is due in part to the fact that the thermalfusion process integrates the materials together to form a unitarysegment rather than a set of independent layers of materials as seen inconventional techniques. Where welding is used on the fabrics andmaterials, the gradients in properties can be designed to be verygradual.

Moreover, because the thermal fusion process typically involves applyingsignificant pressure to the material, the materials involved in theprocess are generally compactified. That is, they are made smaller byvirtue of being integrated together at the fusion regions. As a result,the orthopedic back brace as disclosed herein can advantageously be madesignificantly smaller and more compact than conventional devices.Because the back brace as disclosed herein is less bulky and unwieldy,it is more comfortable to wear than conventional devices. Moreover, thethermal fusion process need not be applied at a defined border region,unlike in stitching processes. Rather, the thermal fusion process may beapplied across a substantial region of the overall materials. As aresult, the resulting unitary segment may substantially less voluminousand may be seamlessly fused together with properties having valuesspread gradually across the segment. In short, unlike conventionaltechniques that use stitched belts with independently acting layers, thebelt members of the back brace disclosed herein may in some embodimentsform a unitary segment that can essentially act as a single integratedmaterial.

FIG. 14A discloses a front posterior view of the belt member 104. Asdescribed above, belt member 104 includes winged member 116 b which inone embodiment includes UBL material. Further included are exteriorlayers 119 b, belt end segments 108, and UBL region 112. FIG. 14Bdiscloses a front anterior view of the belt member 104. The anteriorportion includes winged members 220 b, hook sections 906 a (used in oneembodiment for securing the belt member 104 to D-ring 126 b via a hookand loop connection with winged members 220 b), belt end segment 208 andconnection portion 210. In an embodiment, each of these materials ofbelt member 104 are welded together using thermal fusion to form aunitary segment acting as a single structure and having continuousproperties as described above.

FIG. 15 shows a perspective view of belt member 104 having itscomponents disassembled into their constituent parts. These includewinged members 116 b, exterior layer 119 b, anterior portion 221, wingedmembers 220 b, connection portion 210, glue portion 223, and hookregions 906 a-b. In the embodiment shown, winged members 116 b and 220 bare composed of UBL and are made to be substantially rigid to enable abetter fit against the waist and front torso of the user. This rigiditycan, in one example, be gradually provided to winged members 116 b and220 b by thermally fusing winged members 116 b to exterior layer 119 band by thermally fusing winged members 220 b to anterior portion 210. Inan exemplary embodiment, exterior layer 119 b is composed of TPU. TPUhas several advantages when used in a thermal fusion process. For one,TPU can fuse with other materials, such as hook and loop materials,directly without the use of a filler material. During the thermal fusionof UBL winged members 116 b to exterior TPU layer 119 b, the TPU can actas an adhesive and can melt to integrate with the UBL in winged member116 b. In addition to its ability to act as an adhesive, TPU is aversatile material that can be made to be elastic or inelastic dependingon its thickness. Consequently, where more stretch is desired on a beltmember, TPU can be limited or it can be made thinner. In addition,thermal fusion in general, and particularly thermal fusion of TPU withUBL, causes compression of the integrated materials. This compression ishighly advantageous as it enables the belt to be made smaller, aspreviously described.

Referring still to FIG. 15, exterior layer 119 b may be thermally fusedto anterior portion 221. In an embodiment, anterior portion 221 iscomposed of 3-D spacer mesh. Here again, the TPU of exterior layer 119 bseamlessly fuses with the 3-D spacer mesh of anterior portion 221,compressing the materials further. While in some embodiments theexterior layer 119 b is directly fused to anterior portion 221, in otherembodiments a thin adhesive film may be placed between exterior layer119 b and anterior portion 221 to enable greater control over thebonding process for more consistent bonding.

In a further exemplary embodiment, a hot melt glue board orpolycarbonate section 223 is applied between exterior layer 119 b andanterior portion 221 at an end section 225 of the anterior portion 221and exterior layer 119 b. Because the glue board is rigid at roomtemperature and hardens further during the thermal fusion process,further rigidity to the end section 225 of anterior portion 221 can beprovided for a more controlled and comfortable fit. It should be notedthat end section 225 may generally correspond to the area of one of beltend segments 106 and 108 (FIG. 1). This area corresponds to a frontstomach area of the user, wherein some stiffness is beneficial forcomfort and for ensuring a secure fit, thereby enabling the back braceto properly function. In an exemplary embodiment, the section 223 isonly applied at one of belt segments 106 or 108. Other configurationsmay not utilize section 223.

In addition, connection portion 210 may be thermally fused to ananterior side of anterior portion 221. Winged members 220 b may bewelded to the anterior side of anterior portion 221 in like manner. Inturn, square hook sections 906 a and 906 b may be welded over the wingedmember 220 b. In an embodiment, winged member 220 b is composed of UBL.

FIG. 15 further shows UBL segment 1502 and belt end segments 1504 a-b,also composed of UBL in the present embodiment. UBL segment 1502 andbelt end segments 1504 a-b are thermally fused to exterior layer 119 b.

The amount of materials used, such as the thickness of the TPU and 3-Dspacer mesh, can be controlled to achieve certain target propertieswithin the belt. The use of an adhesive during thermal fusion can bebeneficial in some situations. For example, the adhesive has a lowmelting point such that during welding, the adhesive may melt first andfuse to two other materials that otherwise have higher melting points.

Referring back to FIG. 1, in some embodiments a binding or pipingprocess may be applied along the tangent edge 151 of belt members 102and 104 to secure the edges of the belt members 102 and 104.

The use of welding as described herein has several additionaladvantages. Because most or all of the materials of the belt assemblyare fused together, the welded belt assembly may be made waterproof.Further, the welded belt assembly may be contoured. While conventionalstitching and lamination techniques typically result in flat beltassemblies characterized by essentially two-dimensional features notnaturally aligned with the dimensions of the user's anatomy, thermalfusion can be used in accordance with an embodiment to contour the beltto an effectively three-dimensional shape. More specifically, in thisembodiment, thermal fusion can be used to shape the belt to conform tothe anatomy of a user. This capability may provide a significantadditional benefit of comfort to a user. Moreover, such weldingprocesses can be employed to provide a variety of different shapes andcustomized contours that are configured to fit securely and comfortablygiven a particular user's size and anatomy.

FIG. 16A is a front posterior view of belt member 102, includingexterior layers 119 a, belt end segment 106 and region 110. FIG. 16Afurther defines cross sections A-A and B-B of belt 102. FIG. 16B shows across-sectional view of belt member 102 along plane A-A. The view alongplane A-A coincides in this embodiment with belt end segment 106 andregion 110. Because the belt layers are welded together, the belt member102 can be gradually contoured (1604). While the magnitude of thecontour may be exaggerated for illustration purposes in FIG. 16B, thiscontour can be specifically designed to accommodate the anatomy of auser or class of users and can be customized to meet the needs of userswith different body shapes. FIG. 16C shows a cross-sectional view ofbelt member 102 along plane B-B. Plane B-B corresponds to a central areaof belt member 102 and, as in the previous illustration, this region canbe similarly contoured in an appropriate manner to conform to a user'sanatomy for a secure and comfortable fit. Conventional back braces lackthis feature. In conventional braces, the otherwise flat belt must besecured to the curved shape of a user's anatomy by tightening the beltsufficiently to enable the back brace to properly function. Thistightening may result in additional pressure points and discomfort,particularly after the conventional brace is worn for long periods oftime. FIG. 16D shows a perspective view of the belt member of FIG. 16A.FIG. 17A shows an inverted side view of the belt member 102, includingbelt end segment 106, region 110, exterior layer 119 a, and wingedsection 116 a. FIG. 17B shows a side view of the belt member 102. FIG.18A shows a vertical side view as seen toward the belt end segment 106.FIG. 18B shows a vertical side view of the belt member of FIG. 16A asviewed from a proximal end section of the belt to the distal belt ansegment. In each of these views, the contour may not be drawn to scaleand/or may be enhanced for clarity.

FIG. 19A shows a perspective view of a belt assembly disposed betweentwo tooling molds for use in thermally fusing the belt assembly. Thisfigure illustrates a technique for thermally fusing the belt assembly.Belt member 102 is shaped in this example using tooling core mold 1902,which may form a positive side of a mold, and complementary toolingcavity mold 1904, which may form a negative side of the mold. Thetooling molds 1902 and 1904 may be machined or otherwise constructed toinclude the desired three-dimensional contour as described above, if acontour is desired. In one embodiment, the tooling molds 1902 and 1904are composed of a metal alloy, such as an aluminum alloy, or anothermaterial conducive to transporting heat for use in the fusion process.The various belt layers (see, e.g., FIG. 15) may initially be assembledon top of one another on tooling mold 1902. In an exemplary embodiment,a plurality of pins (not shown) may extend around a perimeter of toolingmold 1902 and may be used to temporarily secure the yet unbonded beltmaterials prior to welding. In other embodiments, other temporaryfastening mechanisms may be used. (In the illustration, belt assembly isseen after welding as a pre-molded belt member 102 having a contour forclarity). Thereupon, the tooling mold 1904, designed with a contour thatcomplements that of tooling shell 1902 fits over tooling mold 1904 andheat and pressure are applied over time to thereby fuse the materialstogether and create an integrated structure which may be contoured.

FIG. 19B shows an inverted perspective view of the belt assembly andtooling molds of FIG. 19A. As shown in the illustration, tooling mold1904 in this example in inwardly contoured in a desired shape toaccommodate the belt assembly and tooling mold 1902.

Advantageously, whereas conventional techniques often require multiplestitching and/or gluing steps to form the resulting belt assembly andspinal support element, the welding process as described with respect toFIGS. 19A-B, above, can often be performed in a single step. Forexample, the material can be fused and contoured concurrently by usingthe above-described tooling molds.

It will be appreciated that alternatively or additionally, portions ofthe spinal support element 114 may also be contoured to form athree-dimensional shape. For example, posterior pad 202 (FIG. 2) may bethermally fused and contoured, whether by itself or along with otherportions of spinal support element 114.

As described above, one benefit of the welding techniques is thatproperties of the belt member 102 itself, and specific regions of thebelt, can be more carefully and strategically controlled than withconventional techniques. As an illustration, belt member 102 may includean exterior layer 119 a composed of TPU (FIG. 1) fused with an anteriorportion 221 composed of 3-D spacer mesh. The fusing of the TPU with thespacer mesh can substantially increase the strength of the fused TPU andspacer mesh as compared with the spacer mesh alone. In addition, thethermal fusion process is flexible. For example, hot melt glue (such asportion 223 in FIG. 15) can be inserted in the belt assembly beingfabricated fused at an end segment 206 or 208 one of belt members 102 or104 (or both) to increase the rigidity of the front section of the beltas worn by a user. This process can be contemporaneous with the beltassembly, as described above.

To demonstrate and verify the effectiveness of the thermal processversus conventional techniques, the inventors compiled test dataregarding the relative stretching of various materials. The test datacan be summarized as follows:

TABLE 1 Stretch Test Stretch Stretch Test Percent Test (mm)- Change(mm)- Distance from Initial with 10 Initial Distance pound load to FinalMaterial without after 2 Distance Description Process Load minutes (%)Spacer Only — 205 245 19.51 TPU Only — 203 225 10.84 Spacer andLongitudinal 200 222 11.00 TPU Stitch Spacer and Vertical Stitch 200 22311.5 TPU Spacer and Welded 200 204 2.00 TPU

Summarizing the data in the above table, the inventors provided thelisted materials and subjected them to a stretch test. The stretch testmeasured an initial distance of the material(s) without the presence ofa stretching load, and a final distance of the material(s) uponapplication of a 10 pound stretching force. When 3-D spacer mesh wasused alone as a benchmark, it was noted that the spacer buckled andnecked substantially and elongated 19.51% as a result of the stretch.The TPU stretch test yielded an elongation of 10.84%. a little greaterthan ½ that of the spacer material. The stretch of the TPU also showedsigns of bucking and necking of the material.

Next, segments of spacer mesh and TPU material were combined usingvertical stitching. That is when viewing the material as a rectanglehaving a height substantially less than its base, the stitching wasdisposed vertically across adjacent left and right edges of therectangle. The combined material was then stretched in the longitudinaldirection (along the long axis of the rectangular material), resultingin an 11.5% elongation. It was apparent to the inventors that, eventhough the spacer mesh and TPU materials were stitched together, the TPUwas sustaining the majority of the tension to hold the materials. It wasconcluded that the stitching of these materials does not create agenerally stronger combination of the two materials.

Thereupon, the same spacer mesh and TPU material was used except thatstitching was also applied longitudinally on each side of the combinedsegment. Thus, stitching traversed the perimeter of the material. Thecombined material was then stretched in the longitudinal direction,resulting in an 11.0% elongation, substantially similar to the case withonly the vertical stitching. The same conclusions were reached as withrespect to the vertical stitching case, and it was further concludedthat the addition of longitudinal stitching does not create a generallystronger combination of the two materials.

Finally, the spacer mesh and TPU material were thermally fused pursuantto the principles described in the present disclosure. Subject to thestretch test, the combined materials elongated a mere 2%—more than fivetimes less than either of the stitched cases. The welded combination isconsequently substantially stronger than the combinations that rely onlyon stitching. The inventors further observed that the fused materialsexhibited minimum buckling and necking. Thus, based on the observeddata, the inventors have concluded that the thermally fused nature ofthe belt assembly as well as, in some embodiments, portions of thespinal support element, yield a stronger, more durable, longer lastingorthopedic back brace as compared to conventional structures.

Table 2 shows a compilation of data taken for various materialcombinations based on the application of the thermal fusion process.Specifically, Table 2 describes the average vertical pull of variousmaterial samples.

TABLE 2 Pull Test Pull test Data Percent (Kilogram-Force Change (kgf))from Material Name (Vertical Average) Spacer Spacer 34.57 NA Spacer +TPU 78.7 127.65 Spacer + Hot Melt 67.04 93.93 Spacer + Hot Melt + 76.43121.09 TPU Spacer + Hot Melt + 82.82 139.57 TPU + UBL

The data in Table 2 indicates, for example, that various characteristics(including strength) of the belt assembly may be achieved usingdifferent material combinations. In other embodiments, different weldingparameters (e.g., temperature, pressure time of exposure) may be used toachieve different characteristics. In Table 2, the different materialcombinations may be used in different regions across the belt assemblyto create gradual property gradients in the belt assembly. Further, thedata reveals that the strength of the welded combination of spacer meshand TPU material is more than twice that of spacer alone. Hot melt maybe used for stiffness and rigidity in select portions of the beltassembly, but the data reveals that the strength is less than the spacermesh/TPU weld. However, it is noteworthy from the data that adding hotmelt to the spacer mesh/TPU combination assists in regaining thatstrength. The data also reveals that the welded combination of spacer,hot melt, TPU and UBL creates the strongest integrated material.

In short, using the principles described herein, the belt segment can bethermally fused to form a single integrated segment havingwell-controlled properties. The light weight, low volume nature of theresulting back brace will consequently be attractive to current users oflarge and bulky orthopedic devices, and new users of such devices.

While the belt segments of the orthopedic back brace have been describedabove as created substantially entirely using thermal fusion, it shouldbe understood that this description is intended to be illustrative innature and that stitching on the belt may also be used. For example, theuse of sewing in one more parts of the belt members may be beneficial orcost effective in some instances such that some embodiments contemplatea belt that is partially integrated using thermal fusion and partiallyformed using conventional means such as stitching. These embodiments,which take advantage of the thermal fusion process to achieve all thebenefits hereinbefore described, are within the scope of the presentdisclosure. It will also be appreciated that the materials describedabove are exemplary in nature, and new or different materials may beused or welded to form the belt assembly and/or the spinal supportelement. In addition, in some embodiments, portions or regions of thebelt assembly and/or spinal support element may be composed of a singlematerial. In still other embodiments, stitching and/or lamination may beused in combination with welding techniques, such as in other portionsof the belt assembly or spinal support element, without departing fromthe spirit and scope of the present disclosure.

It is to be understood that the specific order or hierarchy of steps inthe methods disclosed is an illustration of exemplary processes. Basedupon design preferences, it is understood that the specific order orhierarchy of steps in the methods may be rearranged. The accompanyingmethod claims present elements of the various steps in a sample order,and are not meant to be limited to the specific order or hierarchypresented unless specifically recited therein.

The various aspects of a flexible support presented throughout thisdisclosure are provided to enable one of ordinary skill in the art topractice the present invention. Various modifications to aspectspresented throughout this disclosure will be readily apparent to thoseskilled in the art, and the concepts disclosed herein may be extended toother flexible supports. Thus, the claims are not intended to be limitedto the various aspects of this disclosure, but are to be accorded thefull scope consistent with the language of the claims. All structuraland functional equivalents to the elements of the various aspectsdescribed throughout this disclosure that are known or later come to beknown to those of ordinary skill in the art are expressly incorporatedherein by reference and are intended to be encompassed by the claims.Moreover, nothing disclosed herein is intended to be dedicated to thepublic regardless of whether such disclosure is explicitly recited inthe claims. No claim element is to be construed under the provisions of35 U.S.C. § 112, sixth paragraph, unless the element is expresslyrecited using the phrase “means for” or, in the case of a method claim,the element is recited using the phrase “step for.”

1-30. (canceled)
 31. An orthopedic back brace, comprising: a spinalsupport element; and a waist belt for positioning the spinal supportelement, the waist belt comprising a layer of a thermoplasticpolyurethane having a first elasticity and a pre-welded thickness, and asecond material having a second elasticity and a pre-welded thickness,the thermoplastic polyurethane and second layer thermally fused suchthat a thickness of the thermally fused layers is less that a sum of thepre-welded thicknesses.
 32. The orthopedic back brace of claim 31,further comprising a hybrid layer formed in the fusion process betweenthe thermoplastic polyurethane and the second material, the hybrid layerhaving characteristics of both the thermoplastic polyurethane and thesecond material.
 33. The orthopedic back brace of claim 32, whereinvoids in the thermoplastic polyurethane are used to create directionalcontrol of an elasticity of the belt.
 34. The orthopedic back brace ofclaim 31, further comprising an adhesive layer applied between thethermoplastic polyurethane and the second material prior to the thermalfusion thereof.
 35. The orthopedic back brace of claim 31, wherein thesecond material is a spacer mesh material.
 36. The orthopedic back braceof claim 31, further comprising a thermally fused belt connectionmember.
 37. The orthopedic back brace of claim 31, wherein the belt iscontoured in a direction normal to the plane of the belt during thethermal fusion process.
 38. An orthopedic back brace, comprising: aspinal support element; and a waist belt for positioning the spinalsupport element, the waist belt comprising a layer of a thermoplasticpolyurethane having a first elasticity and a pre-welded thickness, and asecond material having a second elasticity and a pre-welded thickness,the thermoplastic polyurethane and second layer thermally fused to forma hybrid layer between the thermoplastic polyurethane and the secondmaterial, the hybrid layer having characteristics of both thethermoplastic polyurethane and the second material.
 39. The orthopedicback brace of claim 38, wherein voids in the thermoplastic polyurethaneare used to create directional control of an elasticity of the belt. 40.The orthopedic back brace of claim 38, further comprising an adhesivelayer applied between the thermoplastic polyurethane and the secondmaterial prior to the thermal fusion thereof.
 41. The orthopedic backbrace of claim 38, wherein the second material is a spacer meshmaterial.
 42. The orthopedic back brace of claim 38, further comprisinga thermally fused belt connection member.
 43. The orthopedic back braceof claim 38, wherein the belt is contoured in a direction normal to theplane of the belt during the thermal fusion process.
 44. The orthopedicback brace of claim 38, wherein the thermoplastic polyurethane is has asmaller surface area than the second material such that thethermoplastic polyurethane and the second material are both visibleafter the thermal fusion.